MESA LABORATORIES, INC. DataTrace Division
Standard
Operating
Procedure
Release Date: August 27, 2010
Page: 14 of 32
Revision B
6. The first time a new user tries to enter into the program, they will be asked for the login
information that was created by the Administrator. On the first time, and only on the first
time, the new user enters the login entry for both the Login and Password. A dialog box
will appear and require that the new user change to a new Password. Change the
Password as instructed on the dialog box: with a minimum of 8 characters and at least
one of them must be numeric, no spaces.
7. A regular user has only two options for authorization levels: "Data Only" or "Data and
Utilities". No one has access to the Setup options except the Administrator.
While the above discussion defines the Password security that is enabled for both "Simple" and
"Complete" security in DataTrace
®
for Windows, it does not address the additional capabilities
required for "Complete" security. Specifically, this includes "Signing" capabilities required by the
USFDA 21 CFR Part 11, commonly referred to as "Electronic Signatures". The following functions
occur only in “Complete” security mode.
8. Data Signing in DataTrace
®
for Windows requires Tracer reads to be digitally "signed" by
the user. When a Read is attempted, the user is prompted for his/her User ID and
Password. The program then locates and verifies the user record in precisely the same
manner as a login, then further verifies that the login information matches the user that is
currently logged into the system. If successful, the user's private "signing key" is affixed
to the profile along with the User ID.
"Signing Keys" are electronic pairs of encrypted codes that uniquely define that a user is
who they say they are. These keys are a matched pair: one "public" and the other
"private". By comparing and verifying the user's "private" key, the DTW program validates
the target profile. Upon retrieval, the profile exhibits the user's "public" key on the profile.
8. Procedures
This section describes the operation and use of the DataTrace
®
system, including:
DataTrace
®
system connection
Installing
DataTrace
®
for Windows software
Programming
Tracers
for a process study
Reading
collected
data
Analyzing data and generating reports
Verifying
Tracer
calibrations
Calibrating
Tracers
Accessing the audit trail